Study of GV20-0251 in Participants With Solid Tumor Malignancies

GV20 Therapeutics

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Squamous Head and Neck Carcinoma

Solid Tumor Cancer

Melanoma

Endometrial Carcinoma (EC)

Small Cell Lung Cancer

pMMR/MSS Adenocarcinoma of the Colon or Rectum

HCC - Hepatocellular Carcinoma

Adult Refractory Cancer

Non-Small Cell Lung Cancer

Treatments

Drug: GV20-0251

Study type

Interventional

Funder types

Industry

Identifiers

NCT07070518

GV20-0251-300

Details and patient eligibility

About

This is a Phase 1 and Phase 2 study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.

Full description

This is a Phase 1/2A non-randomized, open-label, multi-center study to be conducted in 2 parts (A and B).

Part A is a safety run-in portion. A 3+3 dose escalation scheme will be used to evaluate the safety and tolerability of GV20-0251, and to establish the maximum tolerated dose (MTD) or the preliminary recommended Phase 2 dose (RP2D).

In Part B, the Simon 2-stage design will be utilized to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 at the preliminary RP2D across multiple expansion cohorts involving eligible participants.

Enrollment

350 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Before conducting any study-specific procedures, voluntarily sign an informed consent form.
Be able and willing to participate throughout the entire study period and comply with study procedures.
participants ≥18 years of age
Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy (Refractory or intolerant to standard therapies, must have received the standard of care therapy)
Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression
ECOG performance status of 0 or 1 before C1D1
Part B Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment and on-treatment, if clinically feasible
Disease-free of active second/secondary or prior malignancies for ≥ 2 years Laboratory test results within the required parameters
Women of childbearing potential (WOCBP) and men must agree to use adequate contraception

Exclusion criteria

Participants with acute leukemia or CLL
Participant with heart disease (NYHA ≥ Level II), myocardial infarction within the past 6 months, or unstable arrhythmia
Fridericia-corrected QT interval (QTcF) > 470 msec, or the presence of congenital long QT syndrome, or a history of clinically significant electrocardiogram (ECG) abnormalities (including pericarditis) that, in the investigator's judgment, may affect the subject's safety.
Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy within 7 days before C1D1
Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy
Known human immunodeficiency virus (HIV) infection, known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, unless meeting the specific conditions.
History of major organ transplant and/or a bone marrow transplant
Symptomatic central nervous system (CNS) malignancy or metastasis
Serious nonmalignant disease
Pregnant or nursing women
Major surgery within 28 days prior to the first dose of study medication
Prior anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of GV20-0251 on Cycle 1 Day 1 (C1D1), with the exceptions.
History of severe allergic reactions to biologic therapy, which in the investigator's judgment may increase the subject's risk.
Radiation therapy for symptomatic lesions within 14 days prior to C1D1 dosing.
Active substance abuse
Any history of an immune-related ≥ Grade 3 AE attributed to prior cancer immunotherapy